Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study
Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment, and markedly reduce cost to the VA system. The investigators will compare two technologies; storing the data on secure digital cards to follow the patient versus using secure wireless technology to gather the data, a cloud system to store the data, and staff that would be notified in the event of anomalies in treatment use or effectiveness.
Obstructive Sleep Apnea
Device: Secure digital (SD) card monitoring
Device: Wireless monitoring
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study|
- Postive airway pressure treatment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mean PAP use being > 4 hours per night for greater than 70% of nights.
- PAP treatment efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Evaluate the effect active continuous monitoring among patients with sleep apnea on mean nightly residual respiratory disturbance index (RDI), Epworth Sleepiness Scale, Sleep Apnea Quality of Life Index (SAQLI) and Functional Outcomes Of Sleep Questionnaire. (FOSQ)
- Treatment costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]Compare total costs to patients (sleep clinic visits, travel time, work days missed) and the VA system (travel by homecare providers, sleep clinic visits, supplies) of delivery of OSA management at 30 days, 90 days, 180 days and 1 year between patients receiving conventional CPAP management or active continuous wireless monitoring.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Secure digital (SD) card Monitoring
These patients will be monitored using secure digital (SD) cards as the method to obtain adherence and efficacy data.
|Device: Secure digital (SD) card monitoring|
Experimental: Wireless management
These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
|Device: Wireless monitoring|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678560
|United States, California|
|VA San Diego Healthcare System||Not yet recruiting|
|San Diego, California, United States, 92161|
|Contact: Carl Stepnowsky, PhD email@example.com|
|Contact: Tania Zamora firstname.lastname@example.org|
|Principal Investigator: Carl Stepnowsky, PhD|
|United States, Connecticut|
|VA Connecticut Health System||Not yet recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Meir Kryger, MD email@example.com|
|Contact: Klar Yaggi, MD firstname.lastname@example.org|
|Principal Investigator: Meir Kryger, MD|
|Principal Investigator:||Meir Kryger, MD||VA Connecticut Healthcare System|
|Principal Investigator:||Carl Stepnowsky, PhD||San Diego Veterans Healthcare System|